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Intercept Pharma (NASDAQ: ICPT ): Q1 GAAP EPS of -$3.03 misses by $0.43 . More news on: Intercept Pharmaceuticals, Inc., Earnings news and commentary, Healthcare stocks news, Read more ...
Positive results from pivotal Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to NASH New Drug Application (NDA) filing in the U.S. for OCA in NASH projected in the third quarter of 2019 Worldwide Ocaliva net sales of $51.8 million in the first quarter ...
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Quick Take Axcella Health ( AXLA ) intends to raise $75 million from the sale of its common stock in a U.S. IPO, per an amended registration statement . The company is advancing a pipeline of treatment candidates primarily for liver disease conditions. Given the uncertainties with the f...
NEW YORK, May 01, 2019 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, will announce its first quarter 2019 financial results ...
Nano cap Innovate Biopharmaceuticals (NASDAQ: INNT ) jumps 27% premarket on increased volume in response to its announcement of encouraging data on lead drug larazotide acetate in a mouse model of NASH. The results will be presented at the Analyst Meeting at the Digestive Dis...
Genfit ( GNFT ) announced that it had received Breakthrough Therapy Designation for its drug Elafibranor to treat patients with primary biliary cholangitis ((PBC)). The designation was given based on newly updated data presented at the EASL International Liver Congress 2019. This will help...
Market Assessment Intercept ( ICPT ) is a mid-cap ($2.5B) commercial-stage biopharma that focuses on the clinical development of innovative therapeutics for liver diseases. In Q1/2019, Intercept reported clinical success for obeticholic acid ((OCA)) in the Phase 3 REGENERATE study of pat...
Overview With no current viable treatment options, NASH remains a debilitating disease that hundreds of companies are chasing after. Due to its non-existent list of treatment options that are effective, there is a massive demand. Growing at a CAGR of over 60%, companies are pushing to be fir...
Gilead Sciences ( GILD ) announced two key news items recently. It started off with positive proof of concept NASH results with a double combination treatment, which was presented at the International Liver Congress 2019. Then a few days later, it announced a partnership with Novo Nordisk ( NV...
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MORRISTOWN, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced five abs...
sNDA intended to satisfy post-marketing requirements to confirm a clinical benefit in patients with PBC Precedent-setting submission includes data from post-marketing studies COBALT and Study 401 as well as real-world evidence from a claims database and patient registries FDA has assign...
Data from two Phase 2 studies in PBC show combination of OCA + bezafibrate achieved biochemical remission (normalization of ALP, total bilirubin, GGT, ALT and AST) in 40-44% of patients in the first 12 weeks OCA 5 or 5-10 mg + bezafibrate 400 mg cohorts in both studies showed a >60% ...